带有生物活性涂层的铸造多孔钛植入体在模型系统中的开发和临床前试验

P. A. Karalkin, K. G. Kudrin, D. Svyatoslavov, D. Usatov, I. V. Reshetov
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引用次数: 0

摘要

本文介绍了一种利用添加剂技术制造带有生物活性涂层的定制多孔钛植入体的技术。制作植入体的各个阶段包括:使用计算机断层扫描获取骨缺损区域的原始数据;缺损区域和相应植入体的三维建模;使用选择性激光熔融技术用钛合金制作定制植入体;应用生物活性涂层。制作完成的定制植入体可具有多种功能结构。对带有生物活性涂层的钛植入体样品进行了大量测试。通过数学建模和实验验证了所开发结构的机械性能与天然骨组织的对应关系。对所研究样品进行的体外测试表明,这些样品没有急性毒性,同时具有很高的生物相容性。经当地伦理委员会批准,在苏联栗鼠兔和阿努比斯狒狒猴身上对所研究样品进行的体内测试表明,这些样品具有适当的生物力学特性和较高的骨诱导特性。临床前研究的成功结果,以及在认证实验室进行的毒理学和技术测试,使得利用添加剂技术生产的带有生物活性涂层的定制多孔钛植入物的国家注册档案得以建立。
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Development and Preclinical Trials of Castomized Porous Titanium Implants with Bioactive Coatings in Model Systems
This paper presents a technology for creating customized porous titanium implants with bioactive coatings, manufactured using additive technologies. The stages of creating an implant include obtaining primary data from the bone defect area using computed tomography; 3D modeling of the defect area and the corresponding implant; production of a customized implant from titanium alloys using selective laser fusion technology; application of bioactive coatings. The as-created customized implant can have several functional structures. Samples of titanium implants with bioactive coatings were subjected to extensive testing. Mathematical modeling and experiments were used to verify the correspondence of the mechanical properties of the developed structures to natural bone tissue. In vitro tests of the studied samples showed the absence of acute toxicity along with high levels of biocompatibility. In vivo tests of the studied samples on Soviet chinchilla rabbits and Anubis baboon monkeys approved by local ethical committees showed their adequate biomechanical and high osteoinductive properties. The successful results of preclinical studies, as well as toxicological and technical tests in certified laboratories, made it possible to create a registration dossier for state registration of customized porous titanium implants with bioactive coatings, manufactured using additive technologies.
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